>I realize that formal review of drug delivery products are important for safety Can we be certain of that? How do we define safety? The FDA focuses on ensurin

>I realize that formal review of drug delivery products are important for safety Can we be certain of that? How do we define safety? The FDA focuses on ensuring that no one is harmed by the use of a product, but they pay very little attention to those who are harmed by the lack of access to a product. The institutional incentives that exist encourage this conservative approach to drug access. There are also many forms of regulation outside of governmental regulation. No bureau is needed to verify the quality of my Uber driver, but they still tend to be better than most taxis I've ever taken. 10 years ago you could have said "formal review of taxi drivers is important for safety" and most people would have agreed with you, but fortunately some entrepreneurs realized there was a better form of regulating driver quality.